Drug Approval Package: TRYVIO
Company: Idorsia Pharmaceuticals Ltd.
Application Number: 217686
Approval Date: 3/19/2024
Application Number: 217686
Approval Date: 3/19/2024
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
FDA Approval Letter and Labeling
- Approval Letter(s) (PDF)
- Printed Labeling (PDF)
FDA Application Review Files
- Product Quality Review(s) (PDF)
- Integrated Review (PDF)
- Proprietary Name Review(s) (PDF)
- Officer/Employee List (PDF)
- Other Review(s) (PDF)
- REMS (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Administrative and Correspondence Documents (PDF)
Date created: April 23, 2024
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